NJ-based clinical trial looking into COVID-19 drug Trump has touted

There is no approved medical treatment for COVID-19, the respiratory illness caused by the novel coronavirus.

Researchers at Rutgers Cancer Institute of New Jersey are among those working hard to find a medical solution for symptoms.

A clinical trial, already running for about two weeks now, is still in need of more than 100 COVID-19-positive individuals — with or without a cancer history — who'd be willing to help determine the efficacy of a specific treatment protocol.

Specifically, clinical researchers at Rutgers Cancer Institute want to know whether azithromycin (FDA-approved for the treatment of infections, and better known as a Z-Pak) combined with hydroxychloroquine (FDA-approved for the treatment of malaria and auto-immune diseases) could improve patients' outcomes, compared to hydroxychloroquine alone, or no drugs at all.

It's a combination President Donald Trump has repeatedly touted — despite warnings from some of his medical advisers that it remains unproven.

"Right now we have no idea if there's any benefit," said Steven Libutti, director of the Institute. "Without clinical trials, we never can really understand or know if an agent is effective."

The trial will ideally get 160 patients enrolled. As of Friday, Libutti said, they had about 20. And data can't be gathered until at least 75 patients have been accrued.

"As soon as the patient knows they're positive, if they contact us and they meet eligibility and exclusion criteria, we can have them enrolled in the trial sometimes the same day or the very next day," Libutti said.

Participants must be at least 18 years old, and have to undergo a number of tests including bloodwork and a physical exam prior to being accepted into the clinical trial. Eligible participants will be assigned randomly into three groups: both azithromycin and hydroxychloroquine; hydroxychloroquine alone; or supportive care for six days followed by hydroxychloroquine.

"The goal of our study, or the principal end point, is to determine if the combination of medications ... improves the ability to drive down the amount of virus in the first six days," Libutti said.

The clinical trial is based on findings by French researchers, published in March, that a combination of the two drugs may have helped reduce the viral load in a small number of patients.

For information on how to take part in this clinical trial, individuals can call 732-235-7356 or email statewide_research@cinj.rutgers.edu. The trial is being offered at the Institute in New Brunswick, Robert Wood Johnson University Hospital in New Brunswick, and University Hospital in Newark.